The following data is part of a premarket notification filed by Neurovision, Inc. with the FDA for Aa-1 System.
| Device ID | K012530 |
| 510k Number | K012530 |
| Device Name: | AA-1 SYSTEM |
| Classification | Haploscope |
| Applicant | NEUROVISION, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville, MD 20852 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman NEUROVISION, INC. 12300 TWINBROOK PKWY. SUITE 230 Rockville, MD 20852 |
| Product Code | HJT |
| CFR Regulation Number | 886.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-08-31 |
| Summary: | summary |